Kornimate/medical-research-clean huggingface dataset:
transfusion-requirements in septic shock trial

Conditions: Septic Shock

Summary: patients with blood poisoning - sepsis - often receive blood transfusions in the intensive care unit. the evidence that blood transfusion leads to improved outcome is limited and the blood may be harmful to some of these patients. to bridge the gap between clinical practice and evidence, a large randomised clinical trial is needed to document the efficacy and safety of rbc transfusion in these very sick patients

background septic patients often receive red blood cell (rbc) transfusions in the intensive care unit. the evidence that rbc transfusion leads to improved outcome is limited and the intervention may be harmful to some of these patients. in contrast, current guidelines recommend restrictive transfusion of rbc for critical ill patients without septic shock. to bridge the gap between clinical practice and evidence, a large randomised clinical trial is needed to document the efficacy and safety of rbc transfusion in patients with septic shock design pragmatic, multicenter, randomised, outcome assessment-blinded trial of patients with septic shock to rbc transfusion at haemoglobin (hb) transfusion trigger of 7 g/dl (4.4 mm) or 9 g/dl (5.6 mm), stratified by the presence of haematological malignancy and centre. inclusion and exclusion criteria: to increase the validity of the trial inclusion criteria will be broad with few exclusions outcome measures the outcome measures will mainly be patient-important but icu- and hospital length of stay will also be assessed trial size 2 x 500 patients will be needed to show a 9% absolute risk difference in 90-day mortality (baseline mortality of 45%, relative risk reduction 20% (from septic patients in the tricc trial), alpha of 0.05 (two-sided) and a beta of 0.20 that is a power of 80% (1-beta). an interim-analysis will be performed after 500 patients. the data safety and monitoring board (dmsc) will recommend that the trial is stopped if a group-difference in 90-day mortality with p\<0.001. time line the first patient is expected to be randomised december 1st 2011 and the trial database is expected to be closed early 2014. the main manuscript will be submitted shortly thereafter. funding the trial is publicly funded by the danish strategic research council

Eligibility criteria:
inclusion criteria: * patient in the icu and * fulfil the criteria for septic shock and * have haemoglobin of 9.0 g/dl (5.6 mm) or less and * consent obtainable from patient or proxy or national law allows delayed consent exclusion criteria: * documented wish against transfusion or * previous serious adverse reaction with blood product or * acute coronary syndrome or * life-threatening bleeding or * rbc transfusion during current icu admission or * withdrawal from active therapy or brain death or * lack of informed consent (depending on national law) or * acute burn injury regardless of degree and burn surface area
in vitro evaluation of spontaneous and oxytocin-induced contractility of pregnant human myometrium during exposure to dexmedetomidine

Conditions: Postpartum Hemorrhage

Summary: postpartum hemorrhage (pph) remains to be one of the leading causes of maternal morbidity and mortality. it has been noted that an increasing number of pph is attributed to the increased incidence of uterine atony. myometrial contraction is affected by the choice of anesthetic technique and medications during cesarean delivery (cd). it has been proven that exposure to oxytocin during labor results in a decrease in myometrial contractions. dexmedetomidine is a drug which has been used in obstetric practice due to its desirable effects such as decreasing pain, reduced elevation in blood pressure and heart rate, sedation, and diminished anesthetic requirement. it has been used as an adjunct during spinal or epidural anesthesia during cd and even during general anesthesia for some obstetric surgeries. the use of dexmedetomidine has been continuously rising due to its favorable effects. its use as an adjunct in general anesthesia for obstetrical surgeries has been shown to have promising advantages. during this pandemic, dexmedetomidine has been utilized largely as a sedative in critically ill and intubated patients. this does not exclude critically ill pregnant patients who may also need to deliver urgently. thus, it is important to investigate its effect on uterine contractility on this particular group of patients. the investigators hypothesize that dexmedetomidine causes a dose-dependent increase in contractility of the pregnant human myometrium, both spontaneous and oxytocin-induced.


Eligibility criteria:
inclusion criteria: * pregnant patients scheduled for elective cd under regional anesthesia at 37-41 weeks of gestational age will be included in this study. * only patients for primary cd or repeat cd (1x) will be included in this study since excessive uterine scarring from multiple cd may affect the contractility of myometrial sample. exclusion criteria: * patient refusal * emergency cd * general anesthesia * placenta accreta spectrum disorder * any condition predisposing the patient to uterine atony (e.g. polyhydramnios, multiple gestation) * patients taking medications affecting myometrial contractions(labetalol, magnesium etc.).

Keywords: uterine contraction oxytocin dexmedetomidine
the monarch case series study: sprint® peripheral nerve stimulation for the treatment of head pain

Conditions: Cervicogenic Headache; Occipital Neuralgia

Summary: the purpose of this study is to learn if pain can be relieved by delivering small amounts of electricity (called "electrical stimulation") to the nerves at the top of the neck. this study will use a device called the sprint® pns system. pns stands for peripheral nerve stimulation (pns). this device is cleared by the fda for up to 60 days of use for relief of chronic or acute pain.


Eligibility criteria:
key inclusion criteria: * diagnosed cervicogenic headache (cgh) or occipital neuralgia (on) key exclusion criteria: * prior cervical or cranial occipital surgery * implanted electronic device (dependent on implant's intended treatment, location, and electrical current pathway) * pregnant

Keywords: electrical stimulation neuromodulation head pain headache neck pain
randomized control trial of second stage of labor

Conditions: Labor Complications

Summary: the hypothesis of this study is that extending the second stage of labor beyond current american college of obstetricians and gynecologists suggestions can reduce the cesarean delivery rate. the cesarean delivery rate in the united states is around 30 percent. this is a number that continues to be increasing over the last few decades and will continue to climb. each subsequent cesarean section puts the mother and baby at increased risk for postpartum hemorrhage, bowel and bladder injury, abnormal placentation, febrile morbidity and death. the most common reason for a cesarean delivery is a repeat cesarean delivery. one way to reduce this number is to prevent the first cesarean delivery. the aim of this study is evaluate if extending the second stage of labor affects the cesarean delivery rate and subsequent perinatal morbidity.

1. consent at the time of admission or in the office 2. 2nd stage starts at full dilation 3. randomization occurs at 2 hours without epidural or 3 hours with epidural, stratified by epidural status 4. randomization scheme is according to a predetermined computer-generated block randomization scheme with block sizes of 6,8 and12 (random blocks). 5. sequentially numbered and sealed opaque envelopes prepared according to the randomization scheme and delivered to a secure container in labor and delivery suite to maintain concealed treatment allocation. 6. at the 3 hour mark, the next number envelope is pulled and opened by the physician/nurse to reveal the designated group. at this point the patient is considered randomized. 7. provider preference for cesarean delivery, operative vaginal delivery, continued pushing, with intention-to-treat analysis 8. those that require cesarean delivery - usual perioperative management 9. early termination criteria: emergency cesarean delivery, category 3 fetal heart tracing

Eligibility criteria:
inclusion criteria: * nulliparous women * singleton pregnancies * cephalic presentation * 36.0-41.6 weeks * age 18 and older exclusion criteria: * category 3 fetal heart tracing * major congenital anomalies * multiples * planned cesarean delivery * intrauterine fetal demise * trial of labor after cesarean

Keywords: randomized controlled trial labor complications cesarean section second stage
a retrospective chart review study of the outcomes of 2nd line therapy with len/dex in greek patients with r/r multiple myeloma and the treatment patterns following progressive disease

Conditions: Relapsed/Refractory Multiple Myeloma

Summary: this non-interventional retrospective chart review study aims to evaluate the clinical outcomes of patients with rrmm receiving lenalidomide/dexamethasone (len/dex) treatment at 1st relapse and the treatment patterns following progressive disease as part of the routine clinical practice in greece.


Eligibility criteria:
inclusion criteria: subjects must fulfill all of the following criteria: * subjects of both genders, aged 18 years or older * subjects must have a relapsed or refractory mm diagnosis according to imwg or ebmt criteria * subjects must have initiated second-line therapy with lenalidomide/dexamethasone according to the approved products' summary of product characteristics (smpc) between 01 january 2009 and 01 march 2014 * subjects must have available medical files/records and detailed historical data on their disease course and clinical management * provision of signed icf for collecting and analyzing medical data pertinent to the objectives of this study exclusion criteria: for the candidate subjects none of the following criteria should apply: * prior malignancy (within the 3 years preceding initial diagnosis of mm) * concurrent administration of anti-cancer regimens for malignancies other than mm between the time of initial mm diagnosis and time of second relapse * subject participation in an interventional study
low speed drilling versus conventional drilling technique on crestal bone level in maxilla.(group a ) a randomized controlled clinical trial

Conditions: Bone Resorption

Summary: 20 patients were selected requiring implant placement and divided randomly into two groups (10 in each group) * for the study group, starter drill is used to locate the point of insertion as planned then pilot drill is also used to the full desired working length after that all other sequential drills are used at a low speed (50-70 rpm) without irrigation . * in the study group: implant will be inserted in the low speed osteotomy site. • in the control group: implants will be inserted in the conventional prepared osteotomy site. * for both groups there is no surgical guide used. * the flap will then be copiously irrigated with saline in preparation for closure. * the flap will then be closed using interrupted 4/0 resorbable sutures.


Eligibility criteria:
inclusion criteria: * patients restoring missing maxillary teeth with implant placement. * both sexes. * age: 25-45 * mesio-distal dimensions: not less than 6 mm * bone height: not less than 12 mm * bucco-lingual dimensions: not less than 8mm * all measures will be assessed using cbct. exclusion criteria: * sites needing bone grafting or augmentation. * heavy smokers more than 20 cigarettes per day. * patients with systemic disease that may affect normal healing.
analgesic efficacy of quadratus lumborum, paravertebral blocks

Conditions: Postoperative Pain

Summary: this trial is a prospective, randomized, single-center, single blinded-analysis trial, the objective of which is compare the postoperative analgesia efficacy of quadratus lumborum ii, quadratus lumborum iii and paravertebral blocks in elective laparoscopic cholecystectomy.

laparoscopic approach in cholecystectomy surgery is frequently preferred because of its advantages in systemic complications, morbidity, mortality and hospital stay. pain is one of the important causes of late discharge after surgery. laparoscopic cholecystectomy surgery requires a multimodal analgesia approach because of its multiple pain components.regional analgesia techniques are effective in reducing the side effects such as intraoperative opioid use, postoperative pain and nausea and vomiting. quadratus lumborum block and paravertebral plane blocks are regional techniques performed for multimodal analgesia. the aim of this study is to determine an effective analgesia method by comparing the postoperative analgesic effectiveness of quadratus lumborum ii, quadratus lumborum iii and paravertebral blocks in elective laparoscopic cholecystectomy surgery.

Eligibility criteria:
inclusion criteria: * 18-65 years, american society of anesthesiologists physical statusⅰ-ii exclusion criteria: * local anesthetic allergy * infection at the procedure site * body mass index \>35 kg/m2 * anticoagulant use with bleeding disorder * chronic analgesia and opioid use * with mental and psychiatric disorders

Keywords: paravertebral block quadratus lumborum block laparoscopic cholecystectomy
additional benefits of virtual reality therapy for individuals with neck pain

Conditions: Neck Pain; Virtual Reality; Rehabilitation

Summary: this study aimed to investigate the effect of adding virtual reality therapy to conventional treatment in patients with chronic neck pain on pain, neck disability index, kinesiophobia, insomnia severity questionnaire, hospital anxiety depression scale, cervical range of motion and pressure pain threshold.

neck pain is a disease that affects individuals and society worldwide. between 50% and 85% of the general population experiences neck pain at some point in their lives, and every person who experiences neck pain is likely to experience pain again after 1-5 years. neck pain is considered chronic if it lasts more than 3 months. passive and active physical therapy approaches play a very important role in the treatment of neck pain. with the rapid development of technology, new developments such as virtual reality have begun to be used in the treatment of chronic neck pain. virtual reality (vr) is a term describing innovative, real-time, computer-based technologies that play an increasing role for many patient groups in the field of physical medicine and rehabilitation. virtual reality has been shown to be effective in reducing pain and discomfort in patients with different types of chronic pain. motivation and interaction are the main practical benefits of virtual reality training, especially in video game-based therapy approaches, unlike traditional rehabilitation. patients play the therapeutic game over and over again to achieve a better score without getting bored. feedback, an important component of motor learning, is a prominent feature in virtual environments.

Eligibility criteria:
inclusion criteria: * patients aged 18-65 who signed the informed consent form * those with existing neck pain * those whose neck pain continues for at least 12 weeks exclusion criteria: * previous cervical surgery * having received ftr from the cervical region in the last 6 months * having had a spinal fracture * history of malignancy * those with pacemakers * those with rheumatological, vestibular and neurological diseases * pregnant women
safety follow-up study of inhaled iloprost in patients with pulmonary hypertension

Conditions: Hypertension, Pulmonary

Summary: the aim of this study is to monitor long-term safety and tolerability of iloprost aerosol inhalation therapy in patients suffering from pulmonary hypertension.

this study has previously been posted by schering ag, germany. schering ag has been renamed to bayer schering pharma ag, germany. bayer schering pharma ag, germany is the sponsor of the trial.

Eligibility criteria:
inclusion criteria: * completion of the 12-week treatment period of the predecessor schering study 97218/300180 * investigator judged iloprost aerosol therapy warranted as a suitable treatment for the respective patient * negative pregnancy test for females exclusion criteria: * any condition during 12-week treatment period of the predecessor schering study 97218/300180 that prevents participation in the follow-up safety surveillance study
exercise in pediatric autologous stem cell transplant patients

Conditions: Cancer; Autologous Hematopoietic Stem Cell Transplantation

Summary: hematopoietic stem cell transplantation is an intensive therapy used to improve survivorship and cure various oncologic diseases. however, this therapy is associated with high mortality rates and numerous negative side-effects. the recovery of the immune system is a special concern and plays a key role in the success of this treatment. in healthy populations it is known that exercise plays an important role in immune system regulation, but little is known about the role of exercise in the hematological and immunological recovery of children undergoing hematopoietic stem cell transplant. the primary objective of this randomized controlled trial is: study the effect of an exercise program on immune cell recovery in patients undergoing autologous stem cell transplantation. the secondary objective is to determine if an exercise intervention might diminish the deterioration of quality of life, physical fitness, and the acquisition of a sedentary lifestyle. methods twenty-four participants treated for a malignancy with autologous stem cell transplant (5 to 18 years) in the alberta children's hospital will be randomly assigned to an exercise or control group. the exercise group will participate in a two-phase exercise intervention (in and outpatient) from hospitalization until 10 weeks after discharge. the exercise program includes strength, flexibility and aerobic exercise. during the inpatient phase this program will be performed 5 times/week and will be supervised. the outpatient phase will combine a supervised session with two home-based exercise sessions with the use of the wii device. the control group will follow the standard protocol without any specific exercise program. a range of outcomes, including quantitative and functional recovery of immune system, cytokine levels in serum, nk cells and their subset recovery and function, and gene expression of activating and inhibitory nk cell receptors, body composition, nutrition, quality of life, fatigue, health-related fitness assessment and physical activity levels will be examined, providing the most comprehensive assessment to date. discussion we expect to find an improvement in the immunological recovery, quality of life, decreased acquisition of sedentary behavior and less fitness deconditioning.


Eligibility criteria:
inclusion criteria: * autologous sct at alberta children's hospital (ach) for malignancy * age 5 to 18 years of age * will be receiving myeloablative conditioning regimen * no evidence of cardiac or pulmonary failure associated with treatment (sf≥28%, ef ≥ 50%) * no functional nor cognitive limitation that would prohibit performance of the home-based training * approval by treating oncologist for participants * a parent or legal guardian must sign the consent form and * children should express verbal assent to participate. exclusion criteria: -

Keywords: pediatric exercise hematopoietic stem cell transplantation cancer quality of life immune system physical activity levels
recurrence of hereditary hemorrhagic telangiectasia (hht) after liver transplantation

Conditions: Hereditary Haemorrhagic Telangiectasia; Liver Transplant

Summary: liver transplantation (lt) has been proposed as a curative treatment in hereditary hemorrhagic telangiectasia (hht) with severe hepatic involvement. the investigating team provides a long-term evaluation of graft status after lt for hht with a focus on the risk of recurrence. the present study included all patients prospectively followed up after lt for hht in the lyon liver transplant unit from 1993 to 2010 with a survival of more than 1 year.


Eligibility criteria:
inclusion criteria: * hereditary hemorrhagic telangiectasia (hht) patient who underwent liver transplant for hht exclusion criteria: * patient who died in the year following transplantation
p-chat: comparison of direct to consumer delivery models for hearing devices

Conditions: Hearing Aids; Hearing Loss

Summary: satisfaction and benefit from hearing aids fit using two patient self fit methods will be compared against those fit using audiology-based best practices. individuals between the ages of 50 and 79 years of age will be randomly assigned to one of three fitting methods. benefit and satisfaction will be evaluated six weeks and six months after the initial fitting.

hearing aids are the most pertinent treatment for most adults with hearing loss, a pervasive chronic health problem in \~40% of those over the age of 60 years. only 20% of these individuals purchase and use hearing aids. the over-the-counter hearing aid act of 2017 is designed to increase affordability and accessibility, and thereby adoption, of hearing aids. while this legislation directs the food and drug administration (fda) to create and administer this new channel of hearing aid provision by 2020, best practices related to hearing aid provision without the involvement of a professional, licensed provider have not been explored and established. patients do not have the evidence they need to decide between modes of acquiring hearing aids. the current proposal addresses the specific knowledge gap of efficacious direct-to-consumer hearing aid delivery models. two methods of patient-driven methods of selecting and fitting hearing aids will be compared against audiology-based best practice fitting. individuals who perceive mild or moderate hearing difficulty will be randomly assigned to one of three fitting arms. satisfaction and benefit from hearing aids will be assessed at six weeks and six months after initial fit.

Eligibility criteria:
inclusion criteria: * 50 - 79 years old. * mild or moderate hearing difficulty. * normal cognition. * no prior hearing aid experience. * ability and willingness to pay privately ($650.00) for hearing aids * ability to read and understand english * symmetric hearing loss, no greater than moderate in degree exclusion criteria: -
impact of mandibular overdenture base construction techniques on assessment of occlusion

Conditions: Prosthesis Durability

Summary: this within patient study will be conducted to compare between two different construction techniques (cad-cam milled and conventional techniques) of 4-implant-assisted complete mandibular overdenture bases regarding the digital occlusion force balance analysis using the occlusense


Eligibility criteria:
inclusion criteria: * 1. free from any systemic diseases that contraindicate dental implantation. 2. angel's class i maxillo- mandibular relation. 3. available inter-arch space and sufficient restorative space. 4. nonsmokers, non-alcoholics. 5. complaints from their conventional denture exclusion criteria: * diabetic and heavy smoker patients